Objective Measurement of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively

Cholesteatoma, Middle Ear Clinical Trial

— PalpEar  

Official title:

Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554422
• Other study ID #: 2013-MD-0014
• Status: Completed
• Phase: N/A
• First received: September 15, 2015
• Last updated: September 16, 2015
• Start date: December 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Sensoptic SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Feasibility of the objective measurement of the ossicular chain mobility, by using a force-measuring device based on a fiber optics sensors (PalpEar).

Description:

The aim of this study was to develop and test a palpating instrument, which enables the experienced and occasional otologic surgeon to record force in three dimensions during his standard palpation of each ossicle at surgery and al-lows correlation of his subjective impression with objective measurement results. The first task was to incorporate force sensing capability into a standard 45° angulated 2.5 mm hook, which is commonly used to palpate, disconnect and luxate ossicles during middle ear surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult subjects

• Normally scheduled for middle-ear or internal-ear surgery as a result of an ear disease and for whom a routine assessment of the mobility of the ossicle chain is in order.

The targeted subject population consists of patients undergoing stapedotomy for otosclerosis and subjects with a normal ossicular chain who are subject to the placement of a cochlear implant to treat hearing loss.

Exclusion criteria:

• Children

• Subjects in whom the ossicle chain is missing or incomplete

• Missing informed consent form

• Incapacitated subjects or subjects with impaired judgment capability.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cholesteatoma
• Cholesteatoma, Middle Ear
• Disorder of Middle Ear
• Otosclerosis
• Otosclerosis of Middle Ear

Intervention

Device:
• PalpEar
Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sensoptic SA

References & Publications (10)

Gyo K, Sato H, Yumoto E, Yanagihara N. Assessment of stapes mobility by use of a newly developed piezoelectric ceramic device. A preliminary experiment in dogs. Ann Otol Rhinol Laryngol. 2000 May;109(5):473-7. — View Citation

Hato N, Kohno H, Okada M, Hakuba N, Gyo K, Iwakura T, Tateno M. A new tool for testing ossicular mobility during middle ear surgery: preliminary report of four cases. Otol Neurotol. 2006 Aug;27(5):592-5. — View Citation

Hato N, Stenfelt S, Goode RL. Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurootol. 2003 May-Jun;8(3):140-52. — View Citation

Huber A, Linder T, Ferrazzini M, Schmid S, Dillier N, Stoeckli S, Fisch U. Intraoperative assessment of stapes movement. Ann Otol Rhinol Laryngol. 2001 Jan;110(1):31-5. — View Citation

Koike T, Murakoshi M, Hamanishi S, Yuasa Y, Yuasa R, Kobayashi T, Wada H. An apparatus for diagnosis of ossicular chain mobility in humans. Int J Audiol. 2006 Feb;45(2):121-8. — View Citation

Lau HH, Michler H, Zollner F. Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7

Seidman MD, Standring RT, Ahsan S, Marzo S, Shohet J, Lumley C, Verzal K. Normative data of incus and stapes displacement during middle ear surgery using laser Doppler vibrometry. Otol Neurotol. 2013 Dec;34(9):1719-24. doi: 10.1097/MAO.0b013e3182976528. — View Citation

Shea MC Jr. Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65. — View Citation

Zahnert T, Hüttenbrink KB, Bornitz M, Hofmann G. [Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. German. — View Citation

Zöllner F. Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the ossicle mobility through the palpation force	The palpation forces needed to move the middle-ear ossicles out from their resting position will be measured through a force sensing device. The measured palpation forces are measured in equivalent gram-force [gF]. The primary outcome of the study is to demonstrate if a relation can be established between the subjective feeling of the surgeon and an objective measurement of the palpation force.	1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day.	No
Secondary	Difference between normal and impaired ossicular chains	A comparison between ossicular chains judged as "normal" by the surgeon and impaired ossicular chains will be performed, to assess if a significant difference can be extracted from the measurement of the palpation force. This would help in a future diagnosis assisted by a force sensing device.	1 day. The measurements are performed during day 1, in parallel with the underlying surgery, and therefore assessed within the time frame of 1 day.	No